Trial Outcomes & Findings for Faith-Based Toolbox for African Americans With Dementia (NCT NCT04325204)
NCT ID: NCT04325204
Last Updated: 2024-10-08
Results Overview
Feasibility of the intervention is assessed by how many months it takes to recruit all study participants. The researchers aimed to complete recruitment within 12 months, enrolling 2 to 3 dyads per month.
COMPLETED
NA
54 participants
At enrollment (up to 21 months of study)
2024-10-08
Participant Flow
Participants are dyads of community members in the metropolitan area of Atlanta, Georgia, USA. Participant enrollment began August 19, 2021 and follow-up assessments were completed by July 13, 2023.
Participant milestones
| Measure |
Caregivers
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
During the intervention, participants select activities from Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, music, religious images, and video and audio recorded sermons. Faith-HAT is delivered online, which requires little technical know-how by users. Participants were instructed on how to use Faith-HAT and the online diary via a tablet computer provided by the study.
|
Persons Living With Dementia
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
During the intervention, participants select activities from Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, music, religious images, and video and audio recorded sermons. Faith-HAT is delivered online, which requires little technical know-how by users. Participants were instructed on how to use Faith-HAT and the online diary via a tablet computer provided by the study.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
Began the Intervention
|
26
|
26
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Caregivers
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
During the intervention, participants select activities from Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, music, religious images, and video and audio recorded sermons. Faith-HAT is delivered online, which requires little technical know-how by users. Participants were instructed on how to use Faith-HAT and the online diary via a tablet computer provided by the study.
|
Persons Living With Dementia
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
During the intervention, participants select activities from Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, music, religious images, and video and audio recorded sermons. Faith-HAT is delivered online, which requires little technical know-how by users. Participants were instructed on how to use Faith-HAT and the online diary via a tablet computer provided by the study.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Death of dyad partner, after the intervention and prior to the assessment 6 weeks post-intervention
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
|
Overall Study
Completed the demographic questionnaire but lost to follow-up before beginning the intervention
|
1
|
1
|
Baseline Characteristics
Faith-Based Toolbox for African Americans With Dementia
Baseline characteristics by cohort
| Measure |
Caregivers
n=27 Participants
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
|
Persons Living With Dementia
n=27 Participants
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.30 years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
79.41 years
STANDARD_DEVIATION 7.68 • n=7 Participants
|
68.85 years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At enrollment (up to 21 months of study)Feasibility of the intervention is assessed by how many months it takes to recruit all study participants. The researchers aimed to complete recruitment within 12 months, enrolling 2 to 3 dyads per month.
Outcome measures
| Measure |
Caregivers
n=27 Participants
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
|
Persons Living With Dementia
n=27 Participants
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
|
|---|---|---|
|
Number of Participants Recruited Within the Goal of 12 Months
Enrolled during first 12 months of the study
|
14 Participants
|
14 Participants
|
|
Number of Participants Recruited Within the Goal of 12 Months
Enrolled after the first 12 months of the study
|
13 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: This analysis includes participants who completed the study.
Engagement with the intervention is assessed by the number of participants who reported engaging with Faith-HAT at least two days per week during the 6 week intervention.
Outcome measures
| Measure |
Caregivers
n=17 Participants
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
|
Persons Living With Dementia
n=17 Participants
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
|
|---|---|---|
|
Number of Participants Engaging in the Intervention at Least Two Days Per Week
|
17 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Month 20 of the studyThe feasibility of the intervention is assessed by study retention, specifically, the number of dyads completing the study.
Outcome measures
| Measure |
Caregivers
n=27 Participants
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
|
Persons Living With Dementia
n=27 Participants
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
|
|---|---|---|
|
Number of Dyads Completing the Study
|
17 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: This analysis includes caregiver participants who completed the study.
The amount of burden felt by caregivers was assessed with the 22-item Zarit Burden Inventory. Responses are given on a scale from 0 to 4 where for 0 = never and 4 = nearly always. Total scores range from 0 to 88, where higher scores indicate greater feelings of caregiver burden.
Outcome measures
| Measure |
Caregivers
n=17 Participants
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
|
Persons Living With Dementia
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
|
|---|---|---|
|
Zarit Burden Inventory Score
Baseline
|
36.47 score on a scale
Standard Deviation 13.28
|
—
|
|
Zarit Burden Inventory Score
Week 6
|
32.76 score on a scale
Standard Deviation 14.09
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: This analysis includes caregiver participants who completed the study.
Caregiver stress was assessed with the 14-item Perceived Stress Scale. Responses are given on a scale of 0 to 4 where 0 = never and 4 = very often. Total scores range from 0 to 56 with higher scores indicating greater perceived stress by caregivers.
Outcome measures
| Measure |
Caregivers
n=17 Participants
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
|
Persons Living With Dementia
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
|
|---|---|---|
|
Perceived Stress Scale Score
Week 6
|
30.76 score on a scale
Standard Deviation 5.17
|
—
|
|
Perceived Stress Scale Score
Baseline
|
31.94 score on a scale
Standard Deviation 4.56
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: To decrease the number of surveys administered, reactions to problematic behaviors was used as a marker for depression and was assessed with the Revised Memory and Behavior Problem Checklist. The CES-D instrument was not administered to any participants.
Caregiver depression will be assessed with the 20-item Center for Epidemiologic Studies - Depression Scale. Caregivers are asked how frequently they have experienced specific symptoms of depression in the past week. Responses are given as 0 = rarely, 1 = 1-2 days, 2 = 3-4 days, and 4 = 5-7 days. Total scores range from 0 to 80 with higher scores indicating greater symptoms of depression.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 6Population: This analysis includes caregiver participants who completed the study.
The Revised Memory and Behavior Problem Checklist assesses the presence of problematic behaviors in persons with dementia as well as caregiver distress due to those problems. Caregivers complete the 24-item instrument by indicating whether or not the behavior has occurred and how distressing the behaviors are for them on a scale from 0 to 4 (where 0 = not at all and 4 = extremely). Total scores assessing caregiver reactions to problem behaviors range from 0 to 96 with higher scores indicating greater difficulty with problem behaviors.
Outcome measures
| Measure |
Caregivers
n=17 Participants
Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks.
|
Persons Living With Dementia
Persons living with dementia participating in the Faith-HAT intervention for 6 weeks.
|
|---|---|---|
|
Revised Memory and Behavior Problem Checklist Score
Baseline
|
39.00 score on a scale
Standard Deviation 24.35
|
—
|
|
Revised Memory and Behavior Problem Checklist Score
Week 6
|
38.53 score on a scale
Standard Deviation 24.47
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: The online form used for this survey did not record responses accurately and the information that was collected was not usable.
The Medical Outcomes Study Sleep Scale (MOS-Sleep) measures sleep quality in the past four weeks. The MOS-Sleep includes 12 items assessing the dimensions of sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Nine of the 12 items are used to create a sleep problem index. Scores for each of the dimensions and the sleep problem index are converted to a 0 to 100 scale, where higher scores indicate more of the dimension attribute or increased problems with sleep (for the sleep problem index).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6Population: None of the caregiver participants wore the wristband sensor for 24 hours, thus there were not adequate data for any participant to perform valid calculations of longer-duration heart rate variability. Caregivers reported that wearing the wristband sensor was burdensome and stressful and after the first 5 caregiver participants had unsuccessful attempts for the baseline assessment the investigators discontinued use of the wearable sensor in this study.
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of the time domain of heart rate variability. Mean peak-to-peak intervals will be assessed in seconds. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6Population: None of the caregiver participants wore the wristband sensor for 24 hours, thus there were not adequate data for any participant to perform valid calculations of longer-duration heart rate variability. Caregivers reported that wearing the wristband sensor was burdensome and stressful and after the first 5 caregiver participants had unsuccessful attempts for the baseline assessment the investigators discontinued use of the wearable sensor in this study.
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of the frequency domain, measured in Hertz (Hz), of heart rate variability. Parasympathetic control is characterized as high frequency (0.15-0.40 Hz) while low frequency (0.04-0.15 Hz) characterizes both the sympathetic and parasympathetic activities. Exposure of an individual to a physical or mental stressor activates their stress response through the sympathetic nervous system (SNS) axis. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6Population: None of the caregiver participants wore the wristband sensor for 24 hours, thus there were not adequate data for any participant to perform valid calculations of longer-duration measurement of skin conductance level. Caregivers reported that wearing the wristband sensor was burdensome and stressful and after the first 5 caregiver participants had unsuccessful attempts for the baseline assessment the investigators discontinued use of the wearable sensor in this study.
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of skin conductance level. Skin conductance level is the electrical conductivity of the skin. Skin conducts electricity better during physiological or psychological arousal, making skin conductance level a maker for measuring emotion. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Outcome measures
Outcome data not reported
Adverse Events
Caregivers
Persons Living With Dementia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place